STEMI-RADIAL

A Prospective Randomized Trial of Radial vs. Femoral Access in Patients with ST-Segment

Elevation Myocardial Infarction

I Bernat, D Horak, J Stasek, M Mates, P Ostadal, J Pesek, V Hrabos, J Dusek, J Koza,

Z Sembera, M Brtko, O Aschermann, M Smid, P Polansky, AA Mawiri, J Bis, J Vojacek,

O Costerousse, OF Bertrand, R Rokyta

University Hospital and Faculty of Medicine Pilsen, Regional Hospital Liberec, University Hospital

Hradec Kralove, Na Homolce Hospital Prague, Université Laval Quebec. Czech Republic, Canada

(ClinicalTrials.gov. NCT 00136187)

Disclosure Statement of Financial Interest

I, Ivo Bernat DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

CharacteristicsRIVAL (STEMI)

n=1958

RIFLE-STEACS

n=1001

Sites 158 4

Substudy RIVAL / OASIS 7 no

Primary PCI 74% 92%

Fibrinolytics 12% 7.6%

GPI IIb/IIIa 1/3 2/3

Shock patients no yes

Radial experience variable large

Cross-over 7.6% 9.6%

IABP 1% 8.0%

RIVAL versus RIFLE-STEACS

Jolly et al. Lancet 2011;377:1409-20 Romagnoli et al. JACC 2012 online

STEMI-RADIAL - objectives

To compare radial vs femoral approach in

primary PCI for patients with STEMI < 12 hours

in very high volume radial centers

> 80% radial primary PCI

STEMI-RADIAL - sample size

• Superiority of radial approach compared to femoral in terms of major bleeding and access site complication

• The trial has 80% power to detect 70% relative reduction in major bleeding and access site complications with radial approach compared to femoral approach with an alpha level of 0.05 assuming a reference rate of 6.5%.

STEMI-RADIAL end-points

• Primary - HORIZONS-AMI bleeding and access

site complication *

• Secondary - MACE (death, MI, stroke)

- NACE

- crossover

- angiographic success

- contrast volume

- procedural and fluoroscopic times

- ICU stay

* Hematoma ≥15cm

STEMI-RADIAL - study criteria

Inclusion criteria:

• age over 18 years

• admission for STEMI <12 hours after onset of symptoms

• ability to sign written informed consent

Exclusion criteria :

• Killip IV class or unconsciousness

• Patient refusal

• prior aortobifemoral bypass

• no radial or femoral artery pulse

• participation in another clinical trial

• negative Allen's test or Barbeau test type D

• treatment with oral anticoagulants

STEMI RADIAL - Study design:

707 STEMI patients between October 2009 and February 2012 in 4 PCI centers (24/7)

electronic randomization to femoral or radial approach (www.fnplzen.cz/radial)

femoral approach(n=359)

radial approach(n=348)

Clinical follow-up at 30 days

(100%)

written inform consent in the cathlab

Intention to treat

immediate CAG + pPCI

Four study centers in the Czech Republic

- University Hospital Pilsen

- Regional Hospital Liberec

- University Hospital Hradec Kralove

- Na Homolce Hospital Prague

Patient enrolment

No industry funding

overall (n=707)

Radial (n=348)

Femoral(n=359)

p value

Age (years) 62±11 62±11 61±11 0.16

Male gender 77% 75% 79% 0.24

Weight (kg) 84±15 85±16 83±14 0.056

Hypertension 61% 65% 57% 0.037

Diabetes 21% 22% 19% 0.27

Smoking 51% 48% 55% 0.06

Stroke 4.4% 4.9% 3.9% 0.58

Dyslipidemia 38% 38% 38% 1.00

STEMI RADIAL - baseline characteristics I.

overall (n=707)

Radial (n=348)

Femoral(n=359)

p value

Prior MI 10.6% 9.2% 12% 0.27

Prior PCI 7.2% 7.8% 6.7% 0.66

Prior CABG 0.85% 0.9% 0.8% 1.0

Anterior MI 41% 40% 42% 0.7

Inferior MI 47% 47% 47% 0.88

Lateral MI 13% 14% 13% 0.66

Symptoms to balloon (min) 213(155-296) 215(157-301) 210(150-293) 0.28

STEMI RADIAL - baseline characteristics II.

Radial (n=348)

Femoral(n=359)

p value

Vessel disease 0.93

0 3.7% 3.6%

1 50% 50%

2 31% 30%

3 15% 17%

Killip class 0.14

I. 85% 90%

II. 12% 7.8%

III. 3.4% 2.2%

STEMI RADIAL - procedural characteristics I.

Radial (n=348)

Femoral(n=359)

p value

Initial TIMI 0.55

0 52% 52%

1 13% 13%

2 18% 21%

3 17% 14%

Sheath 0.20

5 F 25% 27%

6 F 75% 72%

7 F 0% 0.8%

overall (n=707)

Radial (n=348)

Femoral(n=359)

p value

Crossover 2.1% 3.7% 0.6% 0.003

GPI IIb/IIIa 45% 45% 45% 0.88

Thromboaspiration 28% 26% 30% 0.32

UFH dose (IU/kg) 104±32 103±34 105±31 0.41

ASA 99% 99% 99% 0.68

Clopidogrel 99% 99% 98% 0.51

Procedural time (min) 49±19 49±20 49±18 1.0

Fluoroscopy time (min) 8.0±5.1 7.9±4.7 8.0±5.5 0.76

STEMI RADIAL - procedural characteristics II.

overall (n=707)

Radial (n=348)

Femoral(n=359)

p value

Angiographic success 91% 91% 91% 0.79

Contrast volume (ml) 176±66 170±71 182±60 0.01

ICU stay (day) 2.8±2.4 2.5±1.7 3.0±2.9 0.0016

Final TIMI 0.62

0 1.3% 1.7% 0.8%

1 1.0% 1.1% 0.8%

2 5.5% 4.9% 6.1%

3 92% 92% 92%

STEMI RADIAL - procedural characteristics III.

STEMI RADIAL - results30-day bleeding and access site compl.

STEMI RADIAL - results30-day bleeding and access site compl.

p=0.0001

80%

p = 0.7

30-day MACE

STEMI RADIAL - results

p = 0.64

p = 0.72

p = 1.0

4.2%

3.5%3.1%

2.3%

0.8%1.2%

0.3% 0.3%

MACE = composite of death, myocardial infarction and stroke

p = 0.0028

30-day NACE

STEMI RADIAL - results

p = 0.7

p = 0.0001

11.0%

7.2%

1.4%

4.2%3.5%

4.6%

Net Adverse Clinical Event (NACE) = MACE + major bleeding MACE = composite of death, myocardial infarction and stroke

80%

58%

Conclusion

• In patients with STEMI <12 hrs, radial approach was associated with a significant lower incidence of major bleeding and access site complications and a significant better net clinical benefit.

• Moreover radial approach reduced significantly ICU stay and contrast volume compared to femoral approach.

• Our results support the use of radial approach in primary PCI in high volume centers as a first choice.

80-year old man from the STEMI-RADIAL trial :

Radial PCI one week after randomization to femoral primary PCI